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Diffusion Pharmaceuticals Announces Results of Phase I Human Trial of Lead Drug Candidate, Trans Sodium Crocetinate (TSC) and Completion of a $4.5 Million Private Placement
Date:9/28/2007

CHARLOTTESVILLE, Va., Sept. 28 /PRNewswire/ -- Diffusion Pharmaceuticals LLC, a clinical-stage drug development company commercializing first-in-class drugs utilizing a novel mechanism of action that enhances oxygen diffusion, today announced the results of a Phase I safety trial of its lead drug candidate, trans sodium crocetinate (TSC). In addition, the company announced the completion of a $4.5 million private placement, the proceeds of which will support the company's overall growth and advance TSC into Phase II clinical trials in early 2008.

Diffusion Pharmaceuticals' initial safety study was a double-blind, placebo-controlled, dose-escalation study designed to evaluate the tolerability and pharmacokinetics of a single intravenous bolus injection of TSC in healthy human subjects. The study demonstrated that TSC is very well-tolerated, raising no significant clinical issues in humans at doses significantly higher than the doses to be used in upcoming clinical trials in patients.

"Successful completion of this study is a key milestone in the clinical development of TSC and significantly advances our lead product candidate toward commercialization," said David G. Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals. "The results of our Phase I trial and recent preclinical studies, coupled with completion of the private placement, will enable us to move quickly into Phase II proof-of-concept studies with TSC in two diverse patient populations -- peripheral vascular disease and cancerous brain tumors -- both of which exhibit oxygen deprivation at the cellular level," said Kalergis.

The company's next clinical study will examine the safety and effects of TSC on oxygenation levels of cancerous tumor tissue in primary brain tumor patients who have glioblastoma multiforme (GBM) and will be undergoing a surgical procedure for tumor biopsy and/or tumor resection. Further trials in GBM patients will examine the safety and effects of TSC,
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SOURCE Diffusion Pharmaceuticals LLC
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